RECRUITING

Neurocognitive Functioning With Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases

Conditions

Brain Metastases whole brain radiation therapy genu of corpus callosum cognitive function

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

This is a trial that evaluates the preservation of cognition and neuropsychiatric function following genu-sparing whole brain radiation in patients with brain metastases.

Official Title

Preservation of Cognition and Neuropsychiatric Functioning With Corpus Callosum Genu-Sparing Whole Brain Radiation Therapy for Brain Metastases: A Pilot Study

Quick Facts

Study Start:2017-07-19

Study Completion:2030-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03223922

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 100 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
* Histologic proof or unequivocal cytologic proof solid tumor malignancy. This may be obtained from either the primary or any metastatic site * Mini Mental State Examination (MMSE) ≥24 * Age≥ 18 years * Karnofsky Performance Status (KPS) ≥70 * Patient does not have metastases to the genu * Patient must be scheduled to undergo treatment with whole brain radiation therapy (WBRT) to manage the brain metastases * Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child * Patient must have the ability to understand and the willingness to sign a written informed consent document * All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines * Patient must have a minimal life expectancy of at least 6 months * Patients receiving prior stereostatic radiosurgery (SRS) for brain metastases are eligible	* Prior WBRT * MMSE\<24 * Patient has brain metastases in the genu * Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits. * KPS\<70 * Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks. * Patients with absolute contraindication to MRI imaging are not eligible for the study

Inclusion Criteria

Exclusion Criteria

* Histologic proof or unequivocal cytologic proof solid tumor malignancy. This may be obtained from either the primary or any metastatic site
* Mini Mental State Examination (MMSE) ≥24
* Age≥ 18 years
* Karnofsky Performance Status (KPS) ≥70
* Patient does not have metastases to the genu
* Patient must be scheduled to undergo treatment with whole brain radiation therapy (WBRT) to manage the brain metastases
* Patients of childbearing potential (male or female) must practice adequate contraception due to possible harmful effects of radiation therapy on an unborn child
* Patient must have the ability to understand and the willingness to sign a written informed consent document
* All patients must be informed of the investigational nature of this study and must be given written informed consent in accordance with institutional and federal guidelines
* Patient must have a minimal life expectancy of at least 6 months
* Patients receiving prior stereostatic radiosurgery (SRS) for brain metastases are eligible

* Prior WBRT
* MMSE\<24
* Patient has brain metastases in the genu
* Patients must not have a serious medical or psychiatric illness that would, in the opinion of the treating physician prevent informed consent or completion of protocol treatment, and/or follow-up visits.
* KPS\<70
* Non-native English speakers will be excluded since patients often lose their faculty with the language they acquired second before their native language is affected in the context of cognitive decline. This could adversely affect performance on verbal cognitive tasks.
* Patients with absolute contraindication to MRI imaging are not eligible for the study

Contacts and Locations

Study Contact

Kristin Redmond, MD

CONTACT

410-614-1642

kjanson3@jhmi.edu

Principal Investigator

Kristin Redmond, MD, MPH

PRINCIPAL_INVESTIGATOR

The SKCCC at Johns Hopkins

Study Locations (Sites)

Sibley Memorial Hospital

Washington, District of Columbia, 20016

United States

The SKCCC at Johns Hopkins

Baltimore, Maryland, 21287

United States

Collaborators and Investigators

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Kristin Redmond, MD, MPH, PRINCIPAL_INVESTIGATOR, The SKCCC at Johns Hopkins

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2017-07-19

Study Completion Date2030-12

Study Record Updates

Study Start Date2017-07-19

Study Completion Date2030-12

Terms related to this study

Keywords Provided by Researchers

whole brain radiation therapy
genu of corpus callosum
cognitive function

Additional Relevant MeSH Terms

Brain Metastases